Catalog Number

-

Brand Name

CVS Health

Version/Model Number

Advanced Early Result Pregnancy Test

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K042280,K042280,K042280

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

c2f7bad2-9f90-4307-9e7d-f9e36d717124

Public Version Date

April 27, 2021

Public Version Number

1

DI Record Publish Date

April 19, 2021

Package DI Number

10050428642488

Quantity per Package

24

Contains DI Package

00050428642481

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

24